Curriculum Vitae Confidential Page * of **

CURRICULUM VITAE

NAME Donna Tindall, RN, MSN

mq7ou4@r.postjobfree.com

LOCATION Delaware, OH 43051 - 35 minutes from the Columbus, Ohio airport

EDUCATION

M.S.N. Clinical Nurse specialist Oncology

Minor in HIV Disease

University of California, San Francisco

San Francisco, California, USA

Bachelors of Science and Nursing

San Jose State University

San Jose, California, USA

Licensed Vocational Nurse

Green River Community College

Auburn, Washington USA

PROFESSIONAL EXPERIENCE

Pharmaceutical Clinical Associates, LLC

Last contract: ImClone Systems, a wholly-owned subsidiary of Eli Lilly And Company

Therapeutic area: oncology

Phases: II - III

Core responsibilities include:

• Site Selection, Site identification and profiling, Site Initiation, Routine Monitoring and Close Out Visits Ensure all Serious Adverse Events (SAEs) are reported according to all applicable regulations

• Evaluate and assist site with adherence to all applicable regulations and guidelines (i.e., GCP, FDA, etc.)

• Verification of proper receipt, dispensation and storage of study drug

• Monitor inclusion and exclusion criteria, primary efficacy and all other study data

• Ensure that the data are correct, complete, and supported by source documentation

• Ensure Informed Consent compliance

• Conducts site visits to ensure source data verification performed according to the monitoring plan, study drug accountability, and compliance to GCPs, ICH guidelines, FDA regulations and applicable SOPs.

• Review and ensure all site regulatory documents are current

• Identify problems associated with study site(s)

• Generates and distributes site inspection reports.

• Assist sites with query resolution

• Written reports to document visits, site deficiencies and site activity

May 2007 – July 2008

Clinical Research Site Manager

KForce

Contracted with: Eli Lilly

Responsibilities include: Multi - Therapeutic and Oncology Trails

Core Responsibilities include:

• Research and seek out potential study investigators

• Identification of potential investigative sites

• Preparation and administration of Confidentiality and Non Use Agreement

• Completion of Site Evaluation checklist

• Conduct Site Evaluation Visit as appropriate

• Utilization of site selection tools, including questionnaires and pre selection checklist

• Completion of Investigator Tracking Log

• Site Management

• Identifies, defines, coordinates and conducts site study training

• Conducts site visits to ensure source data verification performed according to the monitoring plan, study drug accountability, and compliance to GCPs, ICH guidelines, FDA regulations and applicable SOPs.

• Generates and distributes site inspection reports.

• Conducts site close out and assures appropriate archival of regulatory documentation.

• Maintains inspection readiness at the site level.

• Accountable for meeting monitoring timelines and metrics including timeliness of site inspection report submission, CRF backlog, compliance with monitoring intervals as stated in the monitoring plan.

• Issue Resolution; ensures proper escalation of site related issues.

• Communication/Information Management

• Serves as primary point of contact for site personnel regarding study or process related.

• Assist in the identification and selection potential research investigators and sites.

August 2006 to November 2007

i3 Research

Clinical Research Associate

Delaware, OH, USA

Contracted with: Pfizer

Responsibilities include: Critical Care and Oncology Clinical Trails

Core Responsibilities include:

• Research and seek out potential study investigators

• Identification of potential investigative sites

• Preparation and administration of Confidentiality and Non Use Agreement

• Completion of Site Evaluation checklist

• Conduct Site Evaluation Visit as appropriate

• Utilization of site selection tools, including questionnaires and pre selection checklist

• Completion of Investigator Tracking Log

• Site Management

• Identifies, defines, coordinates and conducts site study training

• Conducts site visits to ensure source data verification performed according to the monitoring plan, study drug accountability, and compliance to GCPs, ICH guidelines, FDA regulations and applicable SOPs.

• Generates and distributes site inspection reports.

• Conducts site close out and assures appropriate archival of regulatory documentation.

• Maintains inspection readiness at the site level.

• Accountable for meeting monitoring timelines and metrics including timeliness of site inspection report submission, CRF backlog, compliance with monitoring intervals as stated in the monitoring plan.

• Issue Resolution; ensures proper escalation of site related issues.

• Communication/Information Management

• Serves as primary point of contact for site personnel regarding study or process related.

• Assist in the identification and selection potential research investigators and sites.

PROFESSIONAL EXPERIENCE, CONTINUED

1998 –2003

Global Operations Clinical Coordinator

Clinical Discovery & Human Pharmacology

Aventis Pharmaceuticals, Inc.

Bridgewater, New Jersey, USA

• Clinical Development and Human Pharmacology (CDHP)

(Exploratory through Phase IIb)

• Therapeutic areas: oncology, cardiovascular, metabolism, bone (RA, OA), respiratory, anti-infectives/antifungals, CNS, vaccine

• Responsible for ensuring clinical trials are conducted in accordance with state and federal regulations, GCPs, ICH Guidelines, and Company SOPs by providing required training and maintaining and updating global CDHP training records

• Identifies Department training needs

• Provides, organizes, disseminates and facilitates training globally

• Tracks global training records and ensures compliance

• Responsible for global training audits

• Served as operational liaison providing functional leadership for assigned therapeutic areas with updates on personnel and budgetary requirements

• Assisted in developing outsourcing strategies, monitored status and progress of key study team deliverables, in collaboration with the Global Head of CDHP, Project Team Leaders (PTLs), project teams and support functions

• Managed the implementation and maintenance, monitored the regular progress, and served as a resource to department staff in specific areas of expertise [i.e., overall GCP/SOP training, (SOP Committee representative), e- business systems (IMPACT, GRESDA, etc.).

• Lead in the development of a global multi-therapeutic, cross functional Project Team Operations Manual Research

• Development Day (R&D Day) Preparation Committee Team member. Responsibilities included: acting as chair or assistant chair at preparation meeting, gathering Project data and competitive intelligence in collaboration with Senior Management. Verified Project data and insured the continuity of any subsequent iteration prior to data submission to the Executive Committee.

• Responsible for the development, management and maintenance of a Global Lead Optimization (LO) Web Page for tracking the progress of LO projects. Define web page scope, phases, business plan and budget.

• Analyze and identify web page output requirements for each LO function and develop database interfaces.

o Deliverables include: enabling development of innovative solutions to issues; increasing accessibility to study information and reports; providing project information support to various decision making bodies; enhancing the identification of trends and barriers to progress; support internal benchmarking; develop an integrated information system to link the various databases, systems and processes; reducing redundant data entry in part through the development of web based templates; streamlining and harmonizing the reporting process; enhancing team communication and accessibility to team minutes, monthly summaries and bulletin boards.

• Support the Global Head of LO ad hoc projects as necessary.

• Responsible for tracking progress and presenting status reports regarding the Lead Optimization (LO) global projects, ensuring regular and timely reviews by the Global Lead Optimization Management Team (LOMT),

• Supplied of relevant project information to prepare and facilitate the LOMT project decisions, and track decision realization and implementation.

• Monitored status and progress of key study team deliverables (i.e., Go no/go decisions), in collaboration with the Global Head of CDHP, Project Team Leaders (PTLs), Project Teams and support functions.

• Supported internal global communication to top management by preparing concise informative monthly summaries on the status of cross-therapeutic,

Multiple-sites, LO projects. Additional responsibility included highlighting up-to-date results, milestones, critical issues, and other relevant information.

• Reviewed and provided feedback on the specifications for the execution of agreements for contract research services (i.e., Covance); tracked the progress of outsourced work through to final acceptance of deliverables.

• Reviewed and validated Letters of Agreement including contracts with CROs/vendors, and other affiliates, etc. Ensured a consistent information flow on LO strategy and its implementation and ensuring information flow to the global, multi-therapeutic global LO Project Teams.

1996 –1998

Clinical Research Associate

Clinical Development

Immunex Corporation

Seattle, Washington USA

• Therapeutic area: oncology

• Phase II-III

• Collaborated on protocol development.

• Collaborated on the development of Case Report Forms, monitoring plans and edited specifications.

• Responsible for the site qualification and initiation.

• Prepared study contract and confidentiality agreements. Negotiated clinical budgets and instituted payment schedules.

• Maintained regulatory documentation.

• Prepared protocol amendments.

• Responsible for the management, GCP monitoring and site auditing of several study sites.

• Recruitment of patients

• Ensured adherence to FDA regulations

• Patient eligibility

• Audited source documentation

• Drug accountability

• Queries

1996 to 1997

Senior Clinical Research Coordinator

University of Louisville Medical Center

Blood and Bone Marrow Transplantation Program

Louisville, Kentucky USA

• (Phase IIa – Phase V)

• Therapeutic areas: oncology, antifungal, stem cell research, transplantation,

• Independently responsible for the management of the Blood and Bone Marrow Transplantation Program’s research program

• Managing over 100 in-house treatment protocols. Responsibilities included regulatory documentation, annual reports, SAEs, and several pharmaceutical company sponsored studies, initiation, submission, budget development and negotiation, patient screening and enrollment, data collection, CRF completion, communication with sponsors, monitoring visits, internal audit, close-out visits, query management, and maintenance of study documentation.

• Served as a liaison between the sponsors and the Primary Investigator, pharmacist, nurse clinicians, staff nurses, bone marrow laboratory staff, outpatient clinical staff,

• Responsible for the management and training of research staff and development of a training manual.

• Responsible for both the International Bone Marrow Transplantation Registration for allogenic transplants and autologous transplants and submission packet completion.

• Fulfilled the department’s data submission obligations to the National Transplant cooperative society.

• Reviewed, assessed and applied knowledge of study design to evaluate protocols for logistical feasibility, population availability, personnel and facility requirements, developed timelines for conducting the study, and clarified and communicated study procedures with the sponsors and principle investigator.

• Developed patient tracking system to monitor multiple patients on multiple studies to ensure adherence to protocol requirements.

• Responsible for umbilical cord blood collection and maintained collection protocol.

• Assisted in the development of in-house study protocols including drafting protocols and protocol amendments, created case report forms and source documentation forms such as, flow sheets, developed preprinted medical order forms, and arranged study specific ancillary supplies.

• Responsible for pharmaceutical study management from study initiation, IRB submission, budget development and negotiation, protocol amendments data collection, maintenance of regulatory documentation, screening and assessment of patient enrollment, monitored visits, invoicing, and conduction study termination visits. Arranged for shipment or destruction of unused study materials, ensured completeness of all collected data, queries handled expediently, maintained stored study documentation per FDA regulations.

• Responsible for study accounts

• Reviewed submitted protocols for financial feasibility, asserted equitable clinical costs, assessed cost accounting, developed budgets anticipating expenses to be incurred, negotiated clinical budgets, instituted sponsor payment of indirect cost.

1995 –1996

Clinical Research Coordinator

University of Louisville

Department of Obstetrics and Gynecology

Louisville, Kentucky USA

• Therapeutic areas: GYN/OB, anti-infective, antifungal, device, vaccines

• (Phase III)

• Responsible for managing research protocols, overseeing and initiating patient screening, consenting and accession.

• Maintained accurate documentation, correspondence and study data per FDA regulations.

• Prepared and delivered in-service training to physicians, hospital staff and nurses regarding study protocol requirements.

• Developed framework for the initiation and supervision of research study protocols, developed and maintained computerized data bases and study related forms.

• Worked independently in an advanced practice role as a clinical nurse specialist, performed advanced practice physical assessment and evaluation, acted as blinded clinician performing pelvic exams and slide interpretation.

1996 –1997

Nursing Instructor (Theory and Skills) LVN Program

Spencerian College

Louisville, Kentucky USA

• Responsible for development of teaching plan.

• Nursing skills instruction.

• Taught critical thinking techniques.

• Taught basic nursing theory

1993 – 1995

University of California, San Francisco

Department of Physiological Nursing

San Francisco, California

Research Assistant

1994

American Cancer Association

San Jose, California

Volunteer – Public Information/Speaker

1994 – 1995

Visiting Nurses Association

San Jose, California

Infusion Team Member, Nurse

1989 – 1994

Veterans Administration Hospital

Palo Alto, California

Medical/Surgical, SICU, Transitional Care Unit

Staff and Charge Nurse Positions

1986 – 1989

Manpower Health Care

San Jose, California

Clinic, Home Health Care, and Hospital Staff Nurse

1983 – 1985

Sierra Convalescent Hospital

Auburn, California

Medication and Treatment Nurse

Akalon Nursing Registry

Seattle, Washington

Home Health Care, Convalescent Hospital Staff, Clinical Staff

1974 – 1978

Kline/Galland Home Convalescent Hospital

Seattle, Washington

Medication and Treatment Nurse

POFESSIONAL MEMBERSHIPS

Associates of Clinical Research Professionals

Oncology Nurse’s Society

Sigma Theta Tau, Alpha Gamma Chapter

FOREIGN LANGUAGES

None

HONORS AND AWARDS

Contributing Author: Oncology Nursing: An Essential Guide for Patient Care; W.B. Saunder Company

Sigma Theta Tau Honor Society

San Jose State University Department of Nursing - Outstanding Service Award

Podium Presentation of Thesis Research - 21st Annual Oncology Society Congress; THE OLDER WOMEN’S BREAST CANCER TREATMENT; INWARD FOCUS ON SELF

Aventis achievement award for the development of a Lead Optimization Web Page

Aventis achievement award for contribution to the annual Research and Development Day Presentation to financial analysis’s

SUMMARY OF THERAPEUTIC EXPERIENCE

Antifungal, Bone Marrow Transplantation, Cardiovascular, Central Nervous System, Gyn/OB, Infectious Disease, Metabolic Disease, Oncology, Respiratory Disease, Rheumatoid Arthritis, Vaccines, MS

SUMMARY OF PHASE EXPERIENCE

Exploratory Number of studies ~20

Phase I Number of studies: ~20

Phase II Number of studies: ~20

Phase III Number of studies: ~15

AUTHENTICATION

The information in this document is accurate and complete to the best of my knowledge.

Signature Date

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